1. Field of the Invention
This invention relates generally to orthotic devices generally and particularly to spinal orthotic devices useful to support the spine to provide varying degrees of immobilization of portions of the torso or trunk of the wearer.
2. Description of the Related Art
A common method of alleviating pain and promoting healing after an injury or spinal surgery is to provide stabilization of the patient's trunk and provide support for the involved spinal structural tissues. This is accomplished using a back brace or spinal orthosis. The terms brace and orthosis are used interchangeably herein.
There are a variety of spinal orthosis presently available, each possessing features which achieve varying degrees of support functions regarding the spine or related soft tissues. Of those which are generally accepted as the most useful, each have one or more features related to comfort to the wearer, the ease of use, and cost which also vary in degree. In most instances, one or more of these features are compromised to enhance other features.
Generally, it is accepted that a custom-made spinal orthosis, which is literally formed from a cast of the torso of the intended wearer, is believed to provide the highest degree of stabilization and support. However, custom made devices of this type possess drawbacks related to comfort, expense and the lack of adjustability should the dimensions or other circumstances of the wearer change during the time period required to wear the custom made device.
Highly adjustable devices, which may include elastic components of support, are advantageous relative to fitting a wide size range of persons and may offer some cost advantages. However, many of these devices offer a lesser degree of stabilization and support than desired.
There is also a class or type of spinal brace devices which are known as custom-fit. Such devices include pre-manufactured components which allow for some degree of latitude for fitting a given torso size and configuration. These devices may include adjustable features to achieve a better fit for the individual wearer. However, many of such custom-fit spinal orthosis rely upon flexible, non-rigid portions to achieve a certain degree adjustability or of comfort which may compromise the desired degree of immobilization and support of the wearer's trunk. Others of the custom fit type tend to be relatively limited in adjustment upon fitting and therefore require a greater number of standardized pre-fabricated components in order to accommodate a reasonable percentage of sizes and torso configurations typically encountered in the patient population.
There is a need for an improved custom-fit spinal orthosis of the type described which provides a satisfactory degree of comfort, manufacturing economy, and ease of proper fitting to the wearer, while also providing anterior, posterior, lateral and rotary control of the trunk equivalent to or closely approaching the same degree of immobilization of spinal structures achievable using the custom-made type torso cast.
There is also a need for an improved spinal orthosis which provides anterior and posterior control of the trunk which can be worn by many users suffering from general back pain from time to time due to overuse or less serious back strains which does not require fitting by a trained specialist, yet offers excellent support and adaptability to a wide range of torso sizes.